New system helps researchers with applications

Come June, all U-M research teams seeking approval for biomedical, social or behavioral studies that involve human participants will be using the same electronic system for applications.

The system, called eResearch, aims to make it easier for teams to navigate the complex regulatory environment that governs research conduct. The Web-based system brings a long-anticipated electronic application to medical campus researchers and will be the "next generation" of IRBWebApp, a Web-based system currently used by some researchers.

For investigators and study teams, the new system will streamline the application process and improve project management. The eResearch system will guide study teams through the application and provide information on the status of the application at every point in the review process.

For medical studies, which may be reviewed by as many as eight different committees, eResearch provides one application that will be routed to each group for approval. Under the existing system, study teams often must prepare several different applications for the same study.

The eResearch system has been developed under the auspices of the Michigan Program for Research Information and Education, a cooperative effort of the Office of the Vice President for Research, the Medical School, and Michigan Administrative Information Systems. U-M is configuring software from Click Commerce, Inc. to meet the needs of the University.

The system content was developed with input from faculty and staff at all three campuses, including research faculty, Institutional Review Board (IRB) staff, and staff and reviewers from other review committees.

Akin to popular electronic tax preparation systems, the online application will guide research teams through the process using a "smart form" that presents only sections relevant to the particular study.

Once the routed application arrives at the IRB offices, staff and reviewers will view it online and communicate directly with the study team for any changes required before or after IRB approval. IRB meetings, which also are subject to detailed regulations for their conduct, will be aided by the Web-based system.

Throughout the life of a research project, any renewals, changes, reporting of adverse events, and other business related to the study will be handled through the eResearch system.

After testing, a few research teams started using the system in January. Full availability for IRBMED users is slated for May. Researchers who submit to the IRB-Health and IRB-Behavioral Sciences will begin using the system in June.

Researchers at the Flint and Dearborn campuses also are scheduled to use the eResearch system this year.

Before eResearch replaces existing systems, there will be training sessions across campus for principal investigators, study coordinators, and other staff members or students who will use the eResearch system. There also will be online training and help. Potential users are strongly encouraged to attend training sessions.

The system will help the University conduct research in an ethical manner and in accord with regulations governing research conduct.

"With more than 3,500 active projects each year and a plethora of regulations and guidelines governing research conduct, the task of information management is enormous, and finding ways to stay on top of the information is essential to the University," says Marvin Parnes, associate vice president for research. "For universities that run afoul of compliance regulations, the sanctions can include shutting down research for the entire institution and other costly measures that hamper research programs."

Initially, eResearch will be used for managing human subjects information, but the Web-based information management system also will be applied to other areas of research, including proposal development.

Research teams interested in preparing for eResearch can find information about the system, including a preparation checklist, at http://www.umich.edu/~eresinfo.